Phase 4 Multicenter Infection Surveillance Study Following Cardiac Surgical Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 647
- 试验地点
- 8
- 主要终点
- Hospital Acquired Pneumonia
研究概览
简要总结
The main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.
详细描述
Nosocomial infections are recognized as an important cause of increased patient morbidity and mortality. The reported prevalence for nosocomial infections most commonly ranges from 5 to 20%, but can be significantly greater among patients requiring intensive care. The most common sites of hospital acquired infection include the lung, urinary tract, surgical wounds, and the bloodstream. Patients undergoing cardiac surgery appear to be at increased risk for the development of nosocomial infections due to the presence of multiple surgical wounds (chest and lower extremity incisions), frequent postoperative utilization of invasive devices (i.e. central venous catheters, chest drains, intra-aortic balloon counter pulsation, pulmonary artery catheter), and the common use of prophylactic or empiric antibiotics in the perioperative period. In the cardiac surgical postoperative period, nosocomial infections have been found to be associated with prolonged length of stay (LOS) in the ICU and total hospitalization, development of multiorgan dysfunction, and increased hospital mortality. Nosocomial Pneumonia (NP) is in fact the leading cause of mortality due to hospital-acquired infections. Patients with Ventilator Associated Pneumonia (VAP) have been found in various studies to have significantly higher mortality rates than those without VAP, with ranges of 20.2-45.5% and 8.5-32.2%, respectively. Strategies that both reduce postoperative pain and sedation have the potential to reduce postoperative pneumonia by allowing earlier extubation and more effective pulmonary toilet post-extubation. Non-opioid pain management has the potential to reduce NP rates because of superior pain management, as well as the reduction in opioids required, and the concomitant avoidance of opioid side effects. The clinical and financial consequences of NP justify aggressively pursuing strategies aimed at prevention. Specifically, these strategies are targeted at reducing the incidence of NP by addressing the modifiable risk factors including prolonged endotracheal intubation and ventilator support, sedation, and long hospital LOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, >18 years of age;
- •Scheduled for elective cardiac surgical procedure, including coronary revasculari-zation or valve surgery;
- •Provision of informed consent
排除标准
- •Patients with a prior allergic reaction or dependency to morphine, Demerol, Di-laudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
- •Cardiac transplant patients
- •Inability to perform follow-up assessments;
- •Pre-existing infection (pneumonia or surgical site)
- •Repeat of primary surgery
研究组 & 干预措施
Continuous Sternal Block
Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system
干预措施: Continuous Sternal Block (Device)
Opioid based analgesia
Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics
干预措施: Opioid based analgesia (Drug)
结局指标
主要结局
Hospital Acquired Pneumonia
时间窗: 30 days postoperative
Pneumonia diagnosed during hospitalization
次要结局
- Surgical Site Infection(30 days postoperative)
- Hospital Length of Stay(primary admission)
